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Ziprasidone Improvements Maintained Long-Term In Acute Bipolar Mania: Presented at APA

By Bruce Sylvester

NEW YORK, NY -- May 6, 2004 -- Ziprasidone HCl (Geodon) improves manic symptoms and overall illness severity in acute bipolar mania, and the improvements are maintained over the long-term, researchers report.

"We found from our analysis of the pooled data that ziprasidone is efficacious, and remains so, for a broad range of patients with manic or mixed episodes, including patients with or without psychotic symptoms," said Paul Keck, MD, professor of psychiatry and pharmacology at the University of Cincinnati College of Medicine in Cincinnati, Ohio. Dr. Keck presented the findings this week at the American Psychiatric Association Annual Meeting.

The pooled data came from 2 randomized, double-blind studies involving 415 subjects who were hospitalized with acute bipolar mania. The researchers reported that improvements over the first 3-week study period were significantly greater and more rapid for the subjects who were taking ziprasidone than did those who were taking placebo.

In both studies, the ziprasidone groups began with doses of 80 mg/day. In the first study, the dose was increased to 160 mg/day on day 2. In the second study, titration upward to 120 mg/day on day 2 and 160 mg/day on day 3 was permitted.

Over the course of both initial 3-week studies, ziprasidone was generally well tolerated, with 11% of subjects discontinuing due to treatment-related adverse effects, including somnolence, headache and dizziness.

Results from the 1-year, open-label extension study of 127 patients showed longer-term efficacy and tolerability of ziprasidone therapy among the patients. Patients who started at 80 mg per/day in the original studies were flexibly dosed up to 160 mg per day, with an average dosing during the extension phase of 122 mg per day.

The researchers reported further improvements in manic symptoms (as assessed by the Mania Rating Scale and Clinical Global Impression) over the year and observed no increases in weight, cholesterol, or triglycerides. Concomitant medication was permitted in the extension study.

Ziprasidone (Geodon) is FDA-approved in the U.S. for the treatment of schizophrenia. Ziprasidone was the first atypical antipsychotic approved in both capsule and intramuscular formulations.

[Presentation title: "Efficacy and safety of ziprasidone in bipolar disorder: short- and long-term data."]

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